BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2061369 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02704
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: ALL STAR, WHISPER EXTRA SUPPORT, PROWATER. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. DISSECTION IS A KNOWN ADVERSE EVENT LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION, PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON, AND A 3.5 X 18 PROMUS STENT WAS PLACED SUCCESSFULLY AT THE LESION. AFTER STENT IMPLANTATION, A DISSECTION WAS NOTED; THEREFORE, AN ATTEMPT WAS MADE TO TREAT THE DISSECTION WITH A 3.5 X 12 PROMUS; HOWEVER, THE DEVICE WOULD NOT CROSS THE LESION. THE DISSECTION WAS SUCCESSFULLY TREATED WITH A 3.5 X 12 VISION STENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0071661

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention